Over-the-counter drug · ANDA
Pseudoephedrine Hydrochloride NDC 58602-884
Pseudoephedrine hydrochloride 240 mg/1 · Tablet, Extended release · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-884-27 | 58602088427 | 1 BLISTER PACK in 1 CARTON (58602-884-27) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 29, 2025 | |
| 58602-884-58 | 58602088458 | 2 BLISTER PACK in 1 CARTON (58602-884-58) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 29, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Pseudoephedrine Hydrochloride
- Generic name (nonproprietary)
- pseudoephedrine hydrochloride
- Active ingredients
- Pseudoephedrine hydrochloride — 240 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218854
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 58602-884_77e4132e-470e-4fb4-bc2f-df2e59061ba9SPL ID 77e4132e-470e-4fb4-bc2f-df2e59061ba9SPL set ID 77e4132e-470e-4fb4-bc2f-df2e59061ba9RxCUI 1049670UNII 6V9V2RYJ8N
- Pharmacologic class
- alpha-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458602088427followed by a unit qualifier and the quantityPackage 58602-0884-27. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages relieves sinus pressure
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218854
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pseudoephedrine Hydrochloride | Pseudoephedrine hydrochloride 240 mg/1 | Tablet, Extended releaseOral | WALGREEN CO. | 0363-6611 |